董巍 新版GMP后的挑战和方案

1、2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMP|PallLife Sciencesw/Vivien Dong2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023DisclaimerThis presentation is the Confidential work product of PallCorporation and no portion of this presentation may be copied,p

2、ublished, performed, or redistributed without the expresswritten authority of a Pall corporate officer. 2011 Pall Corporation2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=102312010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023 1P1P5SALz10-645rF0z8z4z5EU GMP Annex 1

3、Manufacture of Sterile Medicinal Products (2008) 83. Where possible, heat sterilisation is the method of choice. 2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMP1SP1140.22Imz84zz54x94x42010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023GMP Annex 1 Manufacture o

4、f Sterile Medicinal Products (2008) 110. P&-44Q54 111. Due to the potential additional risks of the filtration methodas compared with other sterilization processes, a secondfiltration via a further sterilised micro-organism retaining filter,immediately prior to filling, may be advisable. The final s

5、terilefiltration should be carried out as close as possible to the fillingpoint.2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=10235 Decision Trees for the Selection of Sterilisation Methods(CPMP/QWP/O54/98)5Introduction4&555z14/:Aqueous Products)3zF(Non-aqueous Liquid, Semi-solid or

6、 Dry Powder Products)2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023:?4?312010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=10233zF=? rz4=?345F4Z5FZFijklmnopqF182010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023|9:F1#$%(er4z,#$%,r&JKLMLJMLa4“42010版药品

7、GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMPLQSP114ghiiIjz84zz54x94x42010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=10230.2 m0.2 m2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=102354FDA144107/cm2P.diminuta|4(FDA11987)LRVz7/cm220102010版药品GMP指南-全套6本

8、资料/forum.php?mod=viewthread&tid=28747&fromuid=1023k/1;:2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023,FGHx333Ez54P51/P4Y1Q/Fz4r42010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023,GMPLQP443zt-4S1Prx4rz4PrPP1a42010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747

9、&fromuid=1023GMP Annex 1 Manufacture of Sterile Medicinal Products (2008) 112. Fibre-shedding characteristics of filters should be minimal. 113. The time taken to filter a known volume of bulk solution and thepressure difference to be used across the filter should be determinedduring validation and

10、any significant differences from this during routinemanufacturing should be noted and investigated. Results of thesechecks should be included in the batch record. 114. The same filter should not be used for more than one working dayunless such use has been validated. 115. The filter should not affec

11、t the product by removal of ingredientsfrom it or by release of substances into it.2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023Q, Lz_saline lactosebroth, SLBzF-Q, LL = V*VVEVVV-QQ =QV =1V*=zE =QQ-QQ5zF5KQ, LQ, L-Q-QVEEEQ, LQ-QTOCPDA TR26-Q2008 Sterilizing Filtration of Liquids

12、“2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=10231rk2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=102312010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=102360Q60-70:r0.45 m:80:0.2 mQ-ASTM F838-83-1987 FDA190:0.1 m- 1998 PDA F2600Serial /Redundant /Do

13、uble filtration- 2003 EC GMP1- 2004 FDA12010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023Serial /Redundant /Double Serial: events occurring sequentially,.w Double: two together or sequentiallyPz. Redundant: Superfluous, not neededRef.s: , American Heritage Dictionary2010版药品GMP指南-全套

14、6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023Serial /Redundant /Double2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023 Note for guidance on Manufacture of the Finished DosageForm (1996)tF 7. Special Items (/w-)z/7Q4 &10 CFU /100 mlz44Z-8442010版药品GMP指南-全套6本资料/forum.php?mod=v

15、iewthread&tid=28747&fromuid=1023Serial Filtration/:P142010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023/Serial FiltrationP14:BA2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023GMP Annex 1 Manufacture of Sterile Medicinal Products(2008) 111.&1xQ442010版药品GMP指南-全套6本资

16、料/forum.php?mod=viewthread&tid=28747&fromuid=10232010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=102392010:Good Manufacturing Practice (2010 revision)9 :Sx94x42010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023FDA Guidance for Industry Sterile Drug ProductsProduced by

17、Aseptic Processing Current GoodManufacturing Practice, September, 20041Use of redundant sterilizing filtersshould be considered in many cases.“2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=10231 Redundant Filtration A type of serial filtration where a secondsterilizing filter is use

18、d as a backup in the event ofan integrity failure of the primary sterilizing filter*Px&r4* PDA Technical Report 26, Sterilizing Filtration of Liquids(2008 Revision), Glossary2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023(/Serial)+(/Redundant):4414B =BA = 2010版药品GMP指南-全套6本资料/foru

19、m.php?mod=viewthread&tid=28747&fromuid=1023(/Serial) +(/ Double):ABBA2010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023/Serial Filtration:4Qz/Redundant Filtration “/Double Filtration 2 22010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023|-2187L “2010版药品GMP指南-全套6本资料/f

20、orum.php?mod=viewthread&tid=28747&fromuid=102312010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023GMP,-./SPrPP1a401-./2hPP1a44561igg274442010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023 ztrr&42010版药品GMP指南-全套6本资料/forum.php?mod=viewthread&tid=28747&fromuid=1023 *Fz44SupportLayerOuterCageFlow